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AngioDynamics Initiates RECOVER-AV Clinical Trial Assessing AlphaVac F18⁸⁵ System in Treatment of Pulmonary Embolism and Long-Term Functional Outcomes
Multi-center, multi-national study to evaluate mechanical thrombectomy treatment in acute, intermediate-risk PE patients in European Market LATHAM,
About this update from Angiodynamics, Inc.
[{"type":"text","content":"\nMulti-center, multi-national study to evaluate mechanical thrombectomy treatment in acute, intermediate-risk PE patients in European Market\n\n LATHAM, N.Y.--(BUSINESS WIRE)--\nAngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, today announced the launch of the Prospective, Multicenter, Multi-national, Single Arm Trial Evaluating the Efficacy, Safety and long term functional outcomes of percutaneous mechanical aspiration thrombectomy for Treatment of Acute Pulmonary Embolism (PE) using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System (RECOVER-AV).\n\nThe RECOVER-AV trial is designed to evaluate the safety and efficacy of AlphaVac for the treatment of acute, intermediate-risk PE to support its adoption in the European market.\n\nThis study follows the Acute Pulmonary Extraction Trial with AlphaVac (APEX-AV) study, a single-arm Investigational Device Exemption study that enrolled 122 patients with confirmed acute, intermediate-risk PE across 25 hospital-based sites in the United States to assess the AlphaVac F18⁸⁵ System for the treatment of PE. APEX-AV, which completed enrollment in December 2023, demonstrated that the AlphaVac F1885 System is safe in patients with acute intermediate-risk PE and provides significant improvement in right ventricular function and reduction in clot burden.\n\nThe RECOVER-AV study is a multi-center, multi-national trial enrolling patients with confirmed acute, intermediate-risk PE across up to 20 hospital sites in Europe. The primary efficacy endpoint is the reduction of the right ventricular/left ventricular (RV/LV) ratio from baseline to 48 hours post-procedure. The primary safety endpoint focuses on the incidence of Major Adverse Events (MAEs), such as device-related death or major bleeding within seven days. Patients will be followed for 12-months, with functional outcomes assessed at 30-days, six-months, and 12-months.\n\nAn estimated 435,000 PE events occur each year in the six largest European Union (EU) countries.1 Compared to the United States, the prevalence of PE is higher for those patients admitted to the emergency department in Europe, and European patients also had higher acuity and ...